Syros Pharmaceuticals Inc. (SYRS) said that the U.S. Food and Drug Administration has granted Fast Track Designation to tamibarotene for the treatment of higher-risk myelodysplastic syndrome (HR-MDS).
In Thursday pre-market trade, SYRS was trading at $4.61 up $0.17 or 3.82%.
Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARa) agonist, is currently being evaluated in combination with azacitidine for the treatment of newly diagnosed HR-MDS patients with RARA gene overexpression.
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drug candidates intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need.
Syros is evaluating tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients with RARA overexpression in the ongoing SELECT MDS-1 Phase 3 trial.
Syros is evaluating tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients with RARA overexpression in the ongoing SELECT MDS-1 Phase 3 trial.
Syros said it is also evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression, with initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial expected in the fourth quarter of 2023 and additional data in 2024.
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